Cognitive behaviour therapy for chronic fatigue syndrome: a multicentre randomised controlled trial

Background Cognitive behaviour therapy (CBT) seems a promising treatment fo r chronic fatigue syndrome (CFS), but the applicability of this treatment o utside specialised settings has been questioned. We compared CBT with guide d support groups and the natural course in a randomised trial at three cent res. Methods Of 476 patients diagnosed with CFS, 278 were eligible and willing t o take part. 93 were randomly assigned CBT (administered by 13 therapists r ecently trained in this technique for CFS), 94 were assigned the support-gr oup approach, and 91 the control natural course. Multidimensional assessmen ts were done at baseline, 8 months, and 14 months. The primary outcome vari ables were fatigue severity (on the checklist individual strength) and func tional impairment (on the sickness impact profile) at 8 and 14 months. Data were analysed by intention to treat. Findings 241 patients had complete data (83 CBT, 80 support groups, 78 natu ral course) at 8 months. At 14 months CBT was significantly more effective than both control conditions for fatigue severity (CBT vs support groups 5. 8 [2.2-9.4]; CBT vs natural course 5.6 [2.1-9.0]) and for functional impair ment (CBT vs support groups 263 [38-488]. CBT vs natural course 222 [3-441] ). Support groups were not more effective for CFS patients than the natural course. Among the CBT group. clinically significant improvement was seen i n fatigue severity for 20 of 58 (35%), in Karnofsky performance status for 28 of 57 (49%), and self-rated improvement for 29 of 58 (50%). Prognostic f actors for outcome after CBT were a higher sense of control predicting more improvement, and a passive activity pattern and focusing on bodily symptom s predicting less improvement. Interpretation CBT was more effective than guided support groups and the na tural course in a multicentre trial with many therapists. Our study showed a lower proportion of patients with improvement than CBT trials with a few highly skilled therapists.